Dual syringe and methods

ABSTRACT

A method and device for injecting and extracting fluid at a treatment site to remove debris from the site.

CROSS REFERENCE

[0001] The application is a CIP of U.S. Ser. No. 09/637,529 filed Aug.11, 2000; U.S. Ser. No. 09/459,225 filed Dec. 10, 1999; U.S. Ser. No.09/995,303 filed Nov. 27, 2001; U.S. Ser. No. 10/050978 filed Jan. 18,2002; U.S. Ser. No. 10/145,699 filed May 14, 2002. each is incorporatedby reference herein in their entirety.

[0002] This application is a utility case based upon provisionalapplications U.S. No. 60/402,680 filed Aug. 12, 2002 and U.S. No.60/316,122 filed Aug. 30, 2001 each is incorporated by reference hereinin their entirety.

FIELD OF THE INVENTION

[0003] The present invention relates to cardiology and more particularlyto devices and methods for removing debris from vessels.

BRIEF DESCRIPTION OF THE DRAWINGS

[0004] Throughout the figures like reference numerals indicateequivalent structure wherein:

[0005]FIG. 1 is a schematic of the invention;

[0006]FIG. 2 is a schematic of the invention;

[0007]FIG. 3 is a schematic of the invention;

[0008]FIG. 4 is a schematic of the invention;

[0009]FIG. 5 is a schematic of the invention;

[0010]FIG. 6 is a schematic of the invention;

[0011]FIG. 7 is a schematic of the invention;

[0012]FIG. 8 is a schematic of the invention;

[0013]FIG. 9 is a schematic of the invention;

[0014]FIG. 10 is a schematic of the invention;

[0015] Fig. His a schematic of the invention;

[0016]FIG. 12 is a schematic of the invention; and,

[0017]FIG. 13 is a schematic of the invention.

DETAILED DESCRIPTION

[0018]FIG. 8 shows the overall schematic of the treatment system. Aguide sheath 10 with an optional occlusion balloon 12 is navigated tothe treatment site 14. A balloon catheter 16 with a distal fluiddelivery port 18 or nozzle is passed trough the guide catheter 10 to thetreatment site.

[0019] Fluid injected into the catheter 16 emerges from the catheterdistal of the balloon 20 and induces a retrograde flow in the vessel 22.

[0020] The injected fluid may be saline drugs or contrast agent or anybiocompatible fluid. The source of fluid is selected from a conventionalpower injector 30 an irrigation bag suspended above the patient 32, aconventional syringe or a Gemini syringe 34.

[0021] The guide sheath is used to extract debris from the treatmentsite. The outflow passes trough a valve 40, which is associated with aswitch S1. Preferably the valve 40 is actuated by closing S1 and/or themanual actuation of the valve sets the switch S1 to logic 1. The fluiddrawn from the treatment site may be collected in a manual syringe 50the low pressure side of Gemini 34 or a vacuum container 54 or a gravityfed collection bag 52.

[0022] The balloon inflation port 60 is coupled to inflation syringe 62and a deflation vacuum reservoir 64 through a switch valve S2. Inflationof the balloon proceeds normally but deflation is preferably performedin synchrony with the heart. The physician activates the physicianswitch PS when he wants to deflate the balloon 20. Through logic, thevalve S2 is opened and the balloon quickly deflated at an appropriatepoint in the cardiac cycle.

[0023] The catheter is freely movable within the sheath 10 both beforeduring and after the procedure. That is the nozzle 18 can be “on” whilethe catheter is moving relative to the sheath.

[0024]FIG. 1 shows a Gemini dual syringe 69 with an injection outlet 70and an extraction or recovery inlet 72. In this version of the device,it is attached to power injector 80, which maybe turned on, by theswitch S3. The plunger 74 sweeps out a volume and the displaced fluid isinjected out of the port 70. Recovered fluid from the sheath iscollected at port 72. In this fashion the volume injected and extractedare directly coupled.

[0025]FIG. 2 shows a manually operated Gemini dual syringe 73 with ahand plunger 75. This version is useful for interventions where manualcontrol of injection is desired.

[0026]FIG. 3 shows a “universal” Gemini dual syringe 77 where anadditional injection ports 79 and power piston 81 drive a plunger 83.The power inlet port 79 may couple to pump or power injector to controlinjection.

[0027]FIG. 4 and FIG. 5 should be considered together as depicting amethod of removing debris from a vessel. In FIG. 4, the balloon isinflated to treat the lesion 21 in vessel 22. A fluid injection lumen 9in the catheter terminates in a retrograde flow-inducing nozzle 18. Atthe conclusion of the intervention, the balloon is quickly deflatedwhile fluid is injected with nozzle 18. The retrograde flow depicted byarrow 25 sweeps debris indicated by particle 27 into the open mouth ofthe guide catheters. It is preferred to synchronize the balloondeflation with the fluid injection at a time when the flow in the guidecatheter is at a maximum and coronary flow is at a minimum. This flow inthe sheath 10 out the lumen 7 is propelled by either the low pressureside of a Gemini syringe 72 or a manual syringe or a vacuum container 54or a gravity fed bag relying on aortic pressure to force flow in thesheath 10 lumen.

[0028] In the method of FIG. 4 and FIG. 5 The occlusion of the vessel 22with an occlusion balloon 12 is optional and used if the flow in theguide sheath lumen 7 is too low to collect all the injected fluid anddebris.

[0029]FIG. 6 an FIG. 7 show an alternate debris collection concept wherefluid is injected through a guide wire lumen 90 without attempting toinduce a retrograde flow. It should be appreciated that a dedicatedfluid injection lumen may be used as an alternative. In FIG. 6 anintervention takes place normally and in FIG. 7 a large amount of fluidis injected into the vessel distal of the lesion to displace debristoward the open mouth of the guide sheath 10. Particles such as 27 andparticle 29 are forced into the guide sheath where they are evacuated.If the flow rate of the guide sheath exceeds the injected fluid flowrate then the debris will all be sucked out without the use of anoptional occlusion balloon 12.

[0030]FIG. 12 shows a QRS electrocardiograph tracing of the heart over achart showing the time course of pressure in the aorta and flow in thecoronary vessels. The optimal time to inject fluid into the coronaryvessel may be when the flow in the vessels is very low 105 due toventricular contraction. At the isovolumeic, time the aortic pressure isrising very fast 104 and this helps to promote vigorous flow in theguide sheath lumen 7 out of the body.

[0031]FIG. 11 shows a system to create the trigger time signal depictedas 107 in FIG. 12. Conventional surface electrodes over the heart sensethe cardiac depolarization and are amplified in a sense amplifier 109this signal triggers a delay timer which may delay the activation of theremaining circuits for a few milliseconds. Depending on the overallarchitecture of the system any one of several approaches to controllingthe system may be taken.

[0032] For example FIG. 9 assumes that a catheter structure taught byFIGS. 6 and 7 is set up with for example a conventional injector 30coupled to the inlet 9 and a vacuum contain attached to the outlet port40. In this instance, the physician signals his desire to deflate theballoon by activating the physician switch P.S. This is ANDED with thenext RO-wave signal processed to give the heart signal H.S. With the andcondition satisfied the logic 110 drives the switches S! which opens thesheath lumen 7 to the collection vessel. Essentially simultaneously, theballoon 20 is deflated by valve S2. At essentially the same time, theinjector 30 is turned on by switch S3. Under these conditions, theparticles 27 are displaced toward the lumen 7 by the volume of injectedfluid at 9. Of course both anntegrade flow and retrograde flow occurwith the simple fluid injection but the injected volume is set to exceedthe ability of the vascular bed to accept the fluid forcing particulateretrograde into the waiting lumen 7.

What is claimed is:
 1. A syringe having a plunger dividing a cavity intoa low pressure section and an a high pressure section.
 2. A method ofremoving debris from a treatment site comprising the steps of: inflatinga therapy balloon to provide a therapy and thereby occluding the vesseland making debris; injecting fluid distal of said balloon when saidballoon is deflated at a rate and at a time in the cardiac cycle todisplace debris into a guide sheath lumen placed proximal of the therapyballoon. removing debris and fluid from said guide sheath as fluid idsinjected.
 3. A method of removing debris from a treatment sitecomprising the steps of: occluding a vessel near a treatment site byinflating an occlusions balloon located on a guide sheath of the typehaving an open lumen, near the therapy site; injecting fluid into thetherapy site at a location distal of the therapy intervention at a rateand quantity sufficient to displace the debris into said guide sheathlumen.
 4. The method of claim 3 wherein said injecting step is precededby a therapeutic intervention at a site proximal of said injection site.5. The method of claim 2 wherein said injection is synchronized with theelctographic R-wave of the patient.